Clean Rooms are environments in which parameters such as cleanliness, temperature, humidity, pressure and air flow are controlled and monitored, with the aim of promoting a necessary quality standard.
Due to the high risk of contamination, Clean Rooms in hospitals, especially in more critical sectors, such as surgical centers and rooms for patients who have undergone a bone marrow transplant process, are very important.
In the fight against the COVID-19 pandemic, in fact, Clean Rooms were important allies in hospitals.
After all, its environment prevents the circulation of contaminating particles, such as the coronavirus, and, together with asepsis procedures, helps protect the health of patients and professionals.
To ensure this security and avoid errors, however, it is necessary to consider several aspects and create a project.
This article gathers information about some important considerations and standards in creating an efficient and safe project, the role of Clean Rooms in hospitals, must-have items and, as a bonus, comments on a successful Asmontec case.
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Clean Room Technologies applied to hospitals
The Clean Room must be built according to its purpose and, therefore, one of the first steps of the project, naturally, is the mapping of activities.
In the following video, Asmontec's commercial manager comments on the concept and some important considerations in Clean Room projects.
A multidisciplinary team must indicate activities to be performed, equipment, procedures, adequate flows of people, waste or materials, and maintenance needs in a document known as the User Requirements Specification.
The objective of the initiative is to guarantee a higher percentage of correct answers and avoid errors. Therefore, it should also consider norms and main parameters to be followed.
The main standards that guide the construction of Clean Rooms for hospitals are NBR 7256 from ABNT (Brazilian Association of Technical Standards) and Resolution ANVISA RDC 50 (National Health Surveillance Agency).
However, some projects may require the adoption of other standards from these and other institutions, such as the National Institute of Metrology, Quality and Technology (Inmetro), the ISO (International Organization for Standardization) and the FDA (Food and Drug Administration).
ISO 14644, for example, specifies requirements for the design and construction of cleanroom facilities and associated controlled environments, including cleanliness classification in terms of airborne particle concentration and separation devices.
While it does not prescribe specific technological or contractual means to meet these requirements, ISO specifies that internal surfaces have a smooth, non-porous finish without cracks, bumps and indentations and that the finish is compatible with the mechanical and chemical effects of the methods used. of cleaning and sanitization.
Therefore, it is important that the project considers all the details of the Clean Room, which includes its floors, doors, walls, partitions, ceilings and its compositional materials. In general, contaminating particles in the air must be avoided and microbiological control of the environment must be ensured.
The project, therefore, must comply with the technologies that will be used in the Clean Room. For example, the positioning of items such as doors and furniture and even the air flow should be foreseen.
Therefore, it is important that a multidisciplinary team participate in the creation of the project and that international norms and standards are considered.
The aforementioned ISO, for example, provides a checklist for important performance parameters and a construction guide that includes requirements for start-up, qualification and basic elements necessary to ensure continued satisfactory operation.
The role of Cleanrooms in hospital environments
The environment of a room can be contaminated by particles from different sources with external origin, through the opening of doors or windows, for example, or internal, generated by people, activities or even the wear of equipment or furniture.
Of course, this is not an issue every time and some environments have a greater potential for contamination than others. Therefore, areas are usually classified as critical, semi-critical or non-critical according to the associated risk.
Due to the relationship between hospitals and health services, some of their environments are critical and semi-critical, that is, they have a greater risk of contamination and, therefore, the construction of Clean Rooms is essential to guarantee the quality of the environment.
Therefore, surgical centers, areas that perform activities with critical articles or biological materials, such as laboratories, and areas destined to perform invasive procedures need to have the care of a Clean Room.
Thus, it is possible to guarantee safety in the hospital environment, reduce risks related to contamination and dirt and ensure respect for norms and quality standards.
Effective contamination control: which items can't be missed
One of the main items of Clean Rooms, whether in hospitals or in other environments, is the HVAC (Heating, Ventilating and Air Conditioning) or HVAC (Heating, Ventilation and Air Conditioning) System.
After all, the system defines characteristics such as temperature, relative humidity, air flow and exhaustion of the room and, thus, allows controlling the concentration of particles per unit volume of air and guaranteeing the classification of the environment according to the standard.
The system's air conditioning and air filters, in addition to ensuring people's comfort, ensure the asepsis of the place and ideal air quality.
However, it is important to ensure that the other Clean Room equipment conforms to the design. The team then needs to evaluate several items, such as:
- ceilings: the ceiling of the Clean Room must have an opening for light fixtures and be, preferably, continuous, in order to avoid dust and particles;
- partitions: this type of equipment guarantees the necessary isolation from the environment and, in the case of isothermal panels, even the control of humidity and ideal temperature;
- antechambers and pass-throughs: responsible for preventing external air from mixing with the filtered air in the Clean Room;
- luminaires: lighting equipment must be built into the ceiling and must provide protection against dust deposition and enable maintenance, preferably from the external environment to the Clean Room;
- rounded corners: installing joints between floors and walls makes it easier to comply with regulations regarding cleaning and sanitation activities;
- doors: It is important to ensure the environment is sealed, the correct air flow to maintain the segregation of contaminants and the correct handling by operators, which can include manual, spring or automated closing and access control or interlock systems.
It is also necessary to consider and facilitate the cleaning and maintenance activities of walls, ceiling, floor and drains, if they are allowed, with the objective of avoiding the accumulation of particles and microorganisms, and guaranteeing the use of specific clothes, according to the classification of the Clean Room, including by visitors.
Success Case: construction of the Fio Cruz hospital
Asmontec was invited to plan and build a hospital in an initiative of the Oswaldo Cruz Foundation (Fiocruz) with the Ministry of Health in the fight against COVID-19.
The project included the construction of more than 200 beds measuring more than 10 m² and rest areas for the teams in just 60 days.
Contamination control and containment were the main foundations of the project, due to the need to prevent the transmission of the disease from an infected patient to the healthcare team or other people in the hospital.
This was possible through a system with a negative pressure regime with filtration, which prevented the exchange of air between patients, and items such as sealing doors, which allowed Asmontec to meet the project's needs and performance in the fight against the pandemic.
Na project page here on the site, there is more information, a video and several photos of the stages of construction of the hospital.
In summary, an effective and safe hospital Clean Room project requires the collaboration of a multidisciplinary team, the creation of the User Requirements Specification and all the required standards to ensure classification, the optimal quality level and the safety of the environment. . In this sense, the air conditioning system plays an essential role, in addition to other items and attention to activities, flow of people and materials, maintenance and cleaning.
Asmontec has a complete guide on Clean Rooms. The eBook is available at page on this link.
